- The Washington Times - Wednesday, July 7, 2004

Edward Joseph Flynn, the legendary Democratic boss of the Bronx and political counselor to FDR, had a favorite piece of advice for anyone who cared to listen: “Don’t confuse wishes with facts.”

Unfortunately, the sponsors of legislation introduced by Sen. Edward Kennedy and Byron Dorgan to permit drug importation have chosen to ignore this advice. They try to use wishful thinking to convince themselves and members of the American public that opening America’s borders to imported drugs is an instant and risk-free method to lower the cost of prescription drugs.

The bill would allow the importationof drugs from 20 different countries, including drugs not approved by the Food and Drug Administration, into the United States, while offering vague promises that money will somehow be found to beef up that agency for the mammoth job of policing the quality and content of drugs from around the world.

Legalizing drug importation won’t work. That’s the opinion of virtually every public health expert in the United States, including the FDA itself. Even Mr. Ted Kennedy held that position until the Medicare drug benefit passed. Indeed, until a few years ago that opinion also was shared by Dr. David Kessler, the former FDA commissioner who recently elected to provide a series of accommodating answers to a series of orchestrated questions from Mr. Kennedy. The resulting Q&A has become a publicly circulated rationale for the patently unworkable Kennedy-Dorgan bill.

The bill promises money that won’t be forthcoming for protection that won’t be possible. Despite the best intentions of its sponsors, the bill would allow foreign drugs that are substandard, counterfeit or, God forbid, intentionally contaminated by terrorists to flood the United States as legal imports.

As a physician and former assistant secretary for health under Ronald Reagan, I feel obliged to put at least the major fallacies in that Q&A under the microscope of reality.

According to the authors, a capped 1 percent user fee on the value of imported drugs would give the FDA the financial resources it needs to police drug imports. That 1 percent fee is pulled from thin air, since no one knows what the value of legally imported drugs would be, nor does anyone know how it will be collected. We do know from recent FDA testimony that the cost of policing drug imports would run into the “hundreds of millions of dollars,” so there is no guarantee that the user fees would even come close to covering the cost.

Even if money were no object, FDA officials have been candid about saying that they would be hard-pressed to guarantee the safety and purity of every imported prescription drug, as they do with our domestic drug supply. The FDA will have no power to hold foreign exporters accountable for the drugs they send to the United States, and consumers might have no recourse if they were injured.

Furthermore, this legislation doesn’t require, but instead presumes, that imported drugs would be FDA-approved. In fact, the legislation permits the importation of drugs that have not been approved by the FDA, and indeed there is nothing in this legislation that would prohibit the importation of drugs that are not even approved by health authorities in their country of origin. Additionally, many governments do not have the ability to ensure the safety of drugs developed in their own countries and have no intention to do so. To date, many persons have had serious and often fatal reactions to these imported drugs. Some preparations have had no active ingredient, and others have had additional ingredients not intended to be in the product.

With regard to the effect of this proposal on America’s world-leading pharmaceutical and biotech R&D enterprise, there is no question that the importation of drugs will have a crippling effect on research sponsored by industry that far outweighs that provided by the federal government.

As a final reality check on the Kennedy-Dorganlegislation, though, I would just point to the timing. It would go into effect 90 days after passage, an impossibly short time for the FDA to recruit the army of inspectors and technicians needed to even attempt to police drug imports around the world.

On such a high-stakes issue involving the safety of our drug supply and the well-being of our citizens, we cannot afford to confuse wishes with facts.

Dr. Robert E. Windom was assistant secretary for health in the Department of Health and Human Services during the Reagan administration.

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